Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07037459

Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
5,056 (estimated)
Sponsor
Amgen · Industry
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Conditions

Interventions

TypeNameDescription
DRUGMaridebart cafraglutideMaridebart cafraglutide will be administered SC.
DRUGPlaceboPlacebo will be administered SC.

Timeline

Start date
2025-06-25
Primary completion
2028-06-30
Completion
2030-09-29
First posted
2025-06-25
Last updated
2026-04-16

Locations

590 sites across 33 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT07037459. Inclusion in this directory is not an endorsement.